Randomised controlled trial of pulmonary rehabilitation including cognitive behavioural therapy for breathlessness.

Background: Cognitive and exposure-based therapies have the potential to reduce disease specific fears, anxiety and breathlessness. Aim: We hypothesised that adding a specific cognitive behaviour therapy (CBT) program for breathlessness to comprehensive pulmonary rehabilitation (CPR) would result in significantly better health outcomes than those achieved with CPR alone. Methods: Pragmatic clinical trial of people with moderate to severe COPD, block randomised to eight weeks of CPR with CBT (n= 52) or without (n=49). Outcomes included measures of anxiety (Hospital Anxiety and Depression scale HADs), exercise capacity (six-minute walk distance 6MWD) and dyspnoea (Multidimensional Dyspnoea Profile - Affective distress A1) assessed before and one, 6 and 12 months after intervention. Differences between groups were assessed with mixed models comparing each time point to baseline across groups using intention to treat (p≤0.05 significant). Results: 101 participants (mean age 70 ± SD 8.5, 54 males, FEV1 % pred 47.7 ± 16.3) were enrolled. There were no significant differences between groups at baseline or post intervention at one (6MWD (mean diff -3.69 [95%CI -28.84, 21.47], HADs-A -0.38 [-1.96,1.19], A1 -0.1 [-1.2,1.1]), six (6MWD -9.53 [-34.68,15.62], HADs-A 1.30[-0.25,2.86], A1 0.4 [-0.8,1.6]) or 12 months (6MWD -5.17 [-27.53,17.20], HADS-A 0.13 [-1.29,1.56], A1 -0.6 [-1.8,0.5]). Conclusion: Combining CBT+CPR produced comparable results to standard CPR. These findings may reflect cohort characteristics (HADs-A 24 cases, 17 borderline) or the inclusion of covert CBT in standard CPR as a consequence of education and coaching in supervised exercise sessions.